MRI Screening in Men at High Risk of Developing Prostate Cancer
ConditionProstate Cancer Screening
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Chicago
About this trial
The purpose of this study is to determine whether or not Magnetic Resonance Images (MRI) will identify high-grade cancers earlier and more frequently in men at high risk of developing prostate cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male age 18 and older
No known history of prostate cancer
No previous prostate resection or ablation (e.g. TURP, photovaporization)
Disqualifiers
Unable to tolerate MRI due to metal fragments or claustrophobia
Lack of a rectum
Hip arthroplasty
Trial design
Design model
Factorial
Treatments tested in this trial
Prostate MRI
Other interventionGroup placement is determined by GRS score, Family history, and germline testing
Treatment groups
250 Participants
are divided into 4 treatment groupsGroup A: High Risk- Positive Germline Mutation (n=40):Other 1 intervention
Group B: High Risk- High GRS (n=40):Other 1 intervention
Group C: High Risk- Family History (n=45):Other 1 intervention
Group D: Low Risk (n=125):Other 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients with high grade prostate cancer detection.
MRI results will be collected every 3 years for 15 years until high grade prostate cancer is detected as defined as Gleason greater than or equal to 7 (Grade Group 2).
Time frame
Every 3 years up to 15 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov